Pre-hospital Rule-out of Acute Coronary Syndrome

Acute Coronary Syndrome Clinical Trial

— ARTICA  

Official title:

Acute Rule Out of Non ST-segment Elevation Acute Coronary Syndrome in the (Pre)Hospital Setting by HEART Score Assessment and a Single Point-of-care Troponin

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05466591
• Other study ID #: NL 66755.091.18
• Secondary ID: NTR7346NTR734685
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: May 4, 2023

Study information

• Verified date: July 2022
• Source: Radboud University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Patients with chest pain suspected for non ST-segment elevation acute coronary syndrome (NSTE-ACS) are routinely transferred to the emergency department (ED). A point-of-care (POC) troponin measurement might enable ambulance paramedics to identify low-risk patients in whom ED evaluation is not necessary. The ARTICA trial aims to assess the healthcare cost reduction and safety of a pre-hospital rule-out strategy using a single POC troponin measurement.

Description:

Patients with chest pain suspected of a NSTE-ACS are screened by ambulance paramedics. The HEAR score (HEART score without the Troponin component) is assessed and patients with a HEAR score of ≤3 are included. The patients are randomised to 1) pre-hospital rule-out with POC troponin measurement (intervention group) and 2) direct transfer to the ED (standard care group). Primary outcome is healthcare costs after 30 days.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 866
• Est. completion date: May 4, 2023
• Est. primary completion date: June 4, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• Age at least 18 years; male ánd female
• All out-of-hospital patients with chest pain or symptoms suggestive of ACS initially visited by an ambulance with an indication for transfer to a hospital to evaluate and rule out ACS
• Symptom duration for at least two hours
• Modified HEAR(T) score less or equal than 3
• A point of care troponin below the upper reference limit (for patients stratified to pre-hospital management by the general practitioner)
• The patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.

Exclusion criteria:

• Electrocardiographic ST-segment elevation
• Patients presenting an obvious non-cardiac cause for the chest complaints who need evaluation at an emergency department, e.g. trauma, pneumothorax, sepsis, etc.
• Patients in comatose state, defined as an Glascgow coma scale (GCS) <8
• Patients with known cognitive impairment
• Pregnancy or intention to become pregnant during the course of the study
• Patients presenting cardiogenic shock, defined as: systolic blood pressure <90 mmHg and heart rate >100 beats per minute and peripheral oxygen saturation <90% (without oxygen administration)
• Patients presenting with syncope
• Patients presenting with signs of heart failure
• Patients presenting with heart rhythm disorders and second or third degree atrioventricular block
• Patients with known end-stage renal disease (dialysis and/or glomular filtration rate (GFR) < 30 ml/min)
• Patients without a pre-hospital 12-lead ECG performed or available
• Patients suspicious of aortic dissection or pulmonary embolism
• Patients with confirmed acute myocardial infarction, percutaneous coronary intervention or coronary artery bypass grafting <30 days prior to inclusion
• Communication issues with patient/language barrier
• Decision of a present general practitioner to evaluate the patient at the emergency department (ED)
• Decision of the consultant cardiologist to evaluate patient at the ER irrespective of HEART score
• Any significant medical or mental condition, which in the Investigators opinion may interfere with the patients optimal participation in the study

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Syndrome

Intervention

Diagnostic Test:
• Pre-hospital rule-out strategy
Point-of-care troponin measurement for pre-hospital rule-out of acute coronary syndrome

Locations

Country	Name	City	State
Netherlands	RadboudUMC	Nijmegen

Sponsors (2)

Lead Sponsor	Collaborator
Radboud University Medical Center	ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Costs from a healthcare perspective (all costs related to healthcare consumption in-hospital, all outpatient visits including diagnostic tests and general practitioner consultations)	Healthcare costs consist of all costs related to healthcare consumption	30 days
Secondary	Safety: all cause death, acute coronary syndrome, unplanned revascularisation	Major adverse cardiac events (all cause death, ACS, unplanned revascularisation)	30 days
Secondary	Costs from a societal perspective (all health effects and changes in resource use caused by an intervention)	Costs from a societal perspective are defined as the sum of the healthcare costs and the costs from productivity losses.	30 days
Secondary	Safety (all cause death, acute coronary syndrome, unplanned revascularisation)	Major adverse cardiac events (all cause death, ACS, unplanned revascularisation)	6 months
Secondary	Safety (all cause death, acute coronary syndrome, unplanned revascularisation)	Major adverse cardiac events (all cause death, ACS, unplanned revascularisation)	12 months

External Links

•   Study website